SOURCE: Braintree

November 22, 2005 09:00 ET

Holiday Treats Present Temptations and Challenges for Children With GERD

With Imagination, Parents Can Keep the Season Tasty and Fun for Kids

BRAINTREE, MA -- (MARKET WIRE) -- November 22, 2005 -- It seems to begin earlier each year -- freshly picked apples covered in chocolate and caramel fill the aisles in markets all over the country before we've even bid farewell to summer sun. Halloween brings the endless variety of candy awaiting excited trick-or-treaters. The veritable food fest between Thanksgiving and New Year's Day brings tantalizing and tasty delights for all. However, for the large number of U.S. children with acid reflux or gastroesophageal reflux disease (GERD), holiday dining isn't always a happy occasion.

"Avoiding certain foods is key to the management of pediatric GERD. Unfortunately for most children with the condition, the holidays are an especially trying time because their families' rich holiday foods become off limits," said Carlo DiLorenzo, MD, Chief, Pediatric Gastroenterology, Columbus University Children's Hospital and Ohio State University School of Medicine. "Parents can make holiday dining easier for their children by preparing alternate dishes that don't include chocolate or acidic foods like tomatoes and by making sure children take any medications that were prescribed for their condition."

Other helpful tips for managing the symptoms of GERD during the holidays:

--  Take breaks between the courses of holiday dinners.  Eating smaller,
    more frequent meals can aid digestion and prevent some of the symptoms of
    GERD.
    
--  Ensure that children do not eat meals or treats too close to bedtime.
    
--  Avoid foods such as carbonated drinks, chocolate, caffeine, and those
    that contain a lot of acid (citrus, pickles, tomato products) or spicy
    foods.
    
--  Avoid exposing children to tobacco smoke
    
--  Work with the child's doctor to determine if he or she may benefit
    from medications to treat GERD.  One group of medications that aims to
    decrease the amount of acid the stomach produces is called H2-blockers.
    Examples include nizatidine (Axid® OS), ranitidine, famotidine and
    cimetidine(i).
    
--  Find a treatment that is easy for the child to take - large pills or
    harsh-tasting medications will only make a difficult situation worse.  An
    effective H2-blocker like Axid® Oral Solution is more kid-friendly in its
    bubble gum flavored formulation.
    
"The goal of managing a child with GERD is to reduce the amount of stomach acid and contents that 'back up' into the esophagus. The reflux can damage the esophagus, so we try to help parents prevent and reduce GERD symptoms and promote healing through lifestyle changes, but if that doesn't work, medications that reduce the production of stomach acid are also helpful options," DiLorenzo explained.

Almost all children have gastroesophageal reflux as infants, when the stomach contents back up, and such "burping up" after feeding is normal.(ii) Reflux usually improves gradually until age 1 or 2 years, when a child starts eating solid foods and eats upright on his or her own.(iii) However, almost all children and adults have a little bit of reflux, without being aware of it.(iv)(v) But if more substantial reflux occurs, the related symptoms or complications are called Gastroesophageal Reflux Disease (GERD).(vi)

GERD occurs when the muscular ring that closes off the bottom of the esophagus from the stomach briefly relaxes(vii) and then opens during or after a meal. The open "doorway" from the stomach allows food and acid to return to the esophagus and, in some cases, the mouth.(viii)(ix) When refluxed material rapidly returns to the stomach, no damage occurs to the esophagus.(x) But when the stomach contents remain, it can damage the lining of the esophagus.(xi) If the esophageal inflammation is untreated, scarring(xii) or ulcers(xiii) may form. Chronic inflammation also can result in changes to the lining of the esophagus known as Barrett's mucosa, which has the potential to increase the risk of esophageal cancer.(xiv)

While antacids neutralize stomach acid and are available as non-prescription medications, acid suppressants are medications that decrease the stomach's acid production.(xv) One type of acid suppressant is recommended as a first-line therapy for pediatric GERD: the histamine-2 blocker.(xvi) This medicine blocks a receptor on a special type of cell in the lining of the stomach(xvii) that normally helps turn on acid production. Because H2-blockers do not completely turn off acid production, enough acid remains to help a child digest food.(xviii)

AXID® Oral Solution is a treatment for endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to gastroesophageal reflux disease (GERD) for up to 8 weeks. It is an alcohol-free, bubblegum-flavored, formulation of nizatidine approved by the United States Food and Drug Administration for use in pediatric patients aged 12 years and up in May 2004.

The most common adverse experiences in the pediatric study patients were fever, inflammation of the nasal passages and of the upper throat, cough, nasal congestion, vomiting, irritability and diarrhea. Physicians are cautioned to reduce the dose of Axid® Oral Solution in any patients with moderate to severe kidney disease. The drug should not be used in children who have a known hypersensitivity to nizatidine or other H2RA.

About Braintree Laboratories

Braintree Laboratories is a privately held pharmaceutical company that was founded in 1982 in Braintree, Massachusetts. Braintree has several product lines in the US market and holds a leadership position in the therapeutic category of gastrointestinal lavages.

--  Braintree Laboratories pioneered the first gastrointestinal lavage in
    1984 with the introduction of GoLYTELY® (PEG-3350 and Electrolytes for
    Oral Solution), which was soon adopted as a standard prepping procedure.
    
--  NuLYTELY® (PEG-3350, Sodium Chloride, Sodium Bicarbonate and
    Potassium Chloride for Oral Solution) is a reformulation of GoLYTELY®
    that provides improved taste and 52 percent less sodium than previous
    formulations.
    
--  MiraLAX™ (Polyethylene Glycol 3350, NF Powder for Solution) was
    introduced as the first new prescription laxative in 23 years.
    
--  HalfLytely® and Bisacodyl Tablets Bowel Prep Kit (PEG-3350, sodium
    chloride, sodium bicarbonate and potassium chloride for oral solution and
    bisacodyl delayed release tablets) is the latest bowel prep enabling
    patients to ingest 4 bisacodyl tablets and half the volume of solution
    traditionally required.
    
Interested parties who would like more information about AXID® Oral Solution or any other Braintree product should contact the company at 1-800-874-6756 or visit www.axidos.com.

(i) “Gastroesophageal Reflux in Children and Adolescents.” Accessed at http://www.cdhnf.org/pdf/GERDAdolescents_flyer.pdf on October 18, 2005.

(ii) Section: “Children's Health Issues,” Chapter: “Digestive Disorders, Reflux,” The Merck Manual of Medical Information-Second Home Edition online. Copyright © 2004-2005 Merck & Co., Inc., Accessed at http://www.merck.com/mmhe/sec23/ch275/ch275c.html on Sept. 27, 2005.

(iii) Section: “Children's Health Issues,” Chapter: “Digestive Disorders, Reflux,” The Merck Manual of Medical Information-Second Home Edition online. Copyright © 2004-2005 Merck & Co., Inc., Accessed at http://www.merck.com/mmhe/sec23/ch275/ch275c.html on Sept. 27, 2005.

(iv) “Gastroesophageal Reflux in Children and Adolescents,” The National Institute of Diabetes and Digestive and Kidney Diseases, NIH Publication No. 04–5418, December 2003. Accessed online at http://digestive.niddk.nih.gov/ddiseases/pubs/gerinchildren/index.htm on Sept. 27, 2005.

(v) “Guidelines for Evaluation and Treatment of Gastroesophageal Reflux in Infants and Children,” Journal of Pediatric Gastroenterology and Nutrition, Vol 32, Supplement 2, ©2001. Accessed at http://www.naspghan.org/sub/position_papers/GERD.pdf on Sept. 28, 2005.

(vi) “Guidelines for Evaluation and Treatment of Gastroesophageal Reflux in Infants and Children,” Journal of Pediatric Gastroenterology and Nutrition, Vol 32, Supplement 2, ©2001. Accessed at http://www.naspghan.org/sub/position_papers/GERD.pdf on Sept. 28, 2005. p s2.

(vii) “Guidelines for Evaluation and Treatment of Gastroesophageal Reflux in Infants and Children,” Journal of Pediatric Gastroenterology and Nutrition, Vol 32, Supplement 2, ©2001. Accessed at http://www.naspghan.org/sub/position_papers/GERD.pdf on Sept. 28, 2005. p S4.

(viii) Section: “Children's Health Issues,” Chapter: “Digestive Disorders, Reflux,” The Merck Manual of Medical Information-Second Home Edition online. Copyright © 2004-2005 Merck & Co., Inc., Accessed at http://www.merck.com/mmhe/sec23/ch275/ch275c.html on Sept. 27, 2005.

(ix) “Gastroesophageal Reflux in Children and Adolescents,” The National Institute of Diabetes and Digestive and Kidney Diseases, NIH Publication No. 04–5418, December 2003. Accessed online at http://digestive.niddk.nih.gov/ddiseases/pubs/gerinchildren/index.htm on Sept. 27, 2005.

(x) “Gastroesophageal Reflux in Children and Adolescents,” The National Institute of Diabetes and Digestive and Kidney Diseases, NIH Publication No. 04–5418, December 2003. Accessed online at http://digestive.niddk.nih.gov/ddiseases/pubs/gerinchildren/index.htm on Sept. 27, 2005.

(xi) “Gastroesophageal Reflux in Children and Adolescents,” The National Institute of Diabetes and Digestive and Kidney Diseases, NIH Publication No. 04–5418, December 2003. Accessed online at http://digestive.niddk.nih.gov/ddiseases/pubs/gerinchildren/index.htm on Sept. 27, 2005.

(xii) “Guidelines for Evaluation and Treatment of Gastroesophageal Reflux in Infants and Children,” Journal of Pediatric Gastroenterology and Nutrition, Vol 32, Supplement 2, ©2001. Accessed at http://www.naspghan.org/sub/position_papers/GERD.pdf on Sept. 28, 2005. p S4.

(xiii) “Guidelines for Evaluation and Treatment of Gastroesophageal Reflux in Infants and Children,” Journal of Pediatric Gastroenterology and Nutrition, Vol 32, Supplement 2, ©2001. Accessed at http://www.naspghan.org/sub/position_papers/GERD.pdf on Sept. 28, 2005. p S21.

(xiv) “Guidelines for Evaluation and Treatment of Gastroesophageal Reflux in Infants and Children,” Journal of Pediatric Gastroenterology and Nutrition, Vol 32, Supplement 2, ©2001. Accessed at http://www.naspghan.org/sub/position_papers/GERD.pdf on Sept. 28, 2005. p S4.

(xv)Section: “Children's Health Issues,” Chapter: “Digestive Disorders, Reflux,” The Merck Manual of Medical Information-Second Home Edition online. Copyright © 2004-2005 Merck & Co., Inc., Accessed at http://www.merck.com/mmhe/sec23/ch275/ch275c.html on Sept. 27, 2005.

(xvi) “Guidelines for Evaluation and Treatment of Gastroesophageal Reflux in Infants and Children,” Journal of Pediatric Gastroenterology and Nutrition, Vol 32, Supplement 2, ©2001. Accessed at http://www.naspghan.org/sub/position_papers/GERD.pdf on Sept. 28, 2005. p S9.

(xvii) “Guidelines for Evaluation and Treatment of Gastroesophageal Reflux in Infants and Children,” Journal of Pediatric Gastroenterology and Nutrition, Vol 32, Supplement 2, ©2001. Accessed at http://www.naspghan.org/sub/position_papers/GERD.pdf on Sept. 28, 2005. p S9.

(xviii) “H-2 Blockers,” The North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN). Accessed at http://www.naspghan.org/assets/diseaseInfo/pdf/H2Blockers-E.pdf on Sept. 28, 2005.

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